IDEAYA Biosciences, Inc. recently released a business update and announced financial results for the first quarter, which ended on March 31, 2023. As of that date, the company had a strong balance sheet of $351.2 million in cash, cash equivalents, and marketable securities. This was supplemented by estimated net proceeds of $188.7 million from the closing of an underwritten public offering on April 27, 2023, which is expected to fund operations into 2027.
The company has also initiated the Phase 2/3 registrational trial of darovasertib and crizotinib combination in First-Line HLA-A2 negative MUM in Q2 2023, with median PFS as the primary endpoint for potential accelerated approval. Meanwhile, the company reported compelling efficacy data for darovasertib program Phase 2 clinical trials, including in First-Line and Any-Line MUM, as well as additional clinical efficacy as neoadjuvant therapy in primary UM. IDE397 Phase 2 monotherapy expansion international site activation is ongoing, including in Europe and Asia, to enhance patient enrollment in high priority MTAP-deletion tumors.
The company’s preclinical pipeline includes several potential first-in-class synthetic lethal therapeutics on their way to the clinic. Among them, the company is anticipating an IND submission for Pol Theta Helicase DC in Q2 2023 and the selection of the Werner Helicase DC in 2023.
IDEAYA is advancing darovasertib, its protein kinase C, or PKC, inhibitor, with a clinical strategy to broadly address uveal melanoma in both primary and metastatic disease settings. The company reported updated clinical data from the ongoing Phase 2 expansion cohort evaluating darovasertib and crizotinib in MUM. These data demonstrated robust clinical efficacy in first-line MUM patients with a manageable safety profile and support the Company’s plan to initiate a potential registration-enabling Phase 2/3 clinical trial.
IDEAYA is also collaborating with Amgen to evaluate IDE397, its methionine adenosyltransferase 2a, or MAT2A, inhibitor, in combination with AMG 193, the Amgen investigational MTA-cooperative PRMT5 inhibitor, in patients having tumors with methylthioadenosine phosphorylase, or MTAP, gene deletion.
The company’s preclinical pipeline includes several potential first-in-class synthetic lethal therapeutics advancing toward the clinic. GSK is targeting an IND submission in the second quarter of 2023 for a GSK-sponsored Phase 1/2 clinical trial to evaluate the IDEAYA/GSK Pol Theta Helicase inhibitor development candidate (DC) in combination with niraparib for patients having tumors with HRD. The Werner Helicase program continues in collaboration with GSK toward a development candidate nomination in 2023.